SYNCHRONISE: LVO Triage Timing and Outcome Study

Viz.ai

Status: Completed

Conditions: Stroke, Ischemic

Treatments: Other: Baseline Effectiveness Cohort; Device: Viz LVO (De Novo Number DEN170073)

Study type: Observational

Funder types: Industry

Identifiers

NCT04608617

VIZ-LVO-03

Details and patient eligibility

About

The objective of this study is to evaluate the impact of Viz LVO in hospital systems with non-interventional and interventional (spoke and hub) stroke centers on the timing and outcomes of patients with suspected acute ischemic stroke indicated for mechanical thrombectomy.

Full description

This is a multi-center, non-randomized observational study of acute ischemic stroke patients whose CTA scans are analyzed by Viz LVO to support clinicians in making stroke triage decisions,. The study results will be compared to a cohort from enrolling centers prior to Viz LVO implementation that will serve as a historical control. Data will be collected retrospectively from the time of presentation through 90 days post discharge.

The study will include patients undergoing imaging for a suspected LVO acute ischemic stroke. The post-Viz LVO intervention group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, following image analysis by Viz LVO. Data will be collected retrospectively on consecutive patients meeting eligibility criteria from the date of implementation up to 5 years post implementation.

The control group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, for evaluation prior to the implementation of Viz LVO. Data will be collected on consecutive patients from one day prior to implementation, back as far as 2 years prior to implementation

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of 18 years or greater
• Signs and symptoms consistent with the diagnosis of a large vessel occlusive stroke
• Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6
• Aspects Score ≥6
• Patient must have a suspected LVO in M1.
• Patient with an intention to treat with mechanical thrombectomy with confirmation of LVO by the CT/CTA radiographic report with the reading diagnosis.

Exclusion criteria

• Unable to undergo a brain imaging (i.e. severe contrast medium allergy, claustrophobia)

Trial design

600 participants in 2 patient groups

Pre-Viz

Description:

Pre-Viz LVO implementation patient data utilized as a control data set

Treatment:

Other: Baseline Effectiveness Cohort

Post-Viz

Description:

Patient data collected post-Viz LVO implementation

Treatment:

Device: Viz LVO (De Novo Number DEN170073)